Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
NCT ID: NCT02879305
Last Updated: 2021-12-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
2964 participants
INTERVENTIONAL
2016-09-28
2020-11-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daprodustat
Participants will receive oral daprodustat once daily.
Daprodustat
Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
rhEPO
Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).
rhEPO
The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Interventions
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Daprodustat
Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.
rhEPO
The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.
Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Iron therapy
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Eligibility Criteria
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Inclusion Criteria
* Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
* Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb \>11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
* Dialysis: On dialysis \>90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
* Frequency of Dialysis: Hemodialysis (HD) \>=2 times/week and peritoneal dialysis (PD) \>=5 times/week. Home hemodialysis \>=2 times/week.
* Compliance with placebo \[randomization (Day 1) only\]: \>=80% and \<=120% compliance with placebo during run-in period.
* Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria
* Ferritin: \<=100 nanograms (ng)/milliliter (mL) (\<=100 micrograms/liter \[L\]) at screening.
* Transferrin saturation (TSAT) (screening only): \<=20%.
* Aplasias: History of bone marrow aplasia or pure red cell aplasia.
* Other causes of anemia: Untreated Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
* Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \<=4 weeks prior to screening through to randomization (Day 1).
* MI or acute coronary syndrome: \<=4 weeks prior to screening through to randomization (Day 1).
* Stroke or transient ischemic attack: \<=4 weeks prior to screening through to randomization (Day 1).
* Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
* Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of recombinant human erythropoietin (rhEPO).
* Bazett's corrected QT interval (QTcB) (Day 1): QTcB \>500 millisecond (msec), or QTcB \>530 msec in subjects with bundle branch block. There is no QT Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
* Alanine transaminase (ALT): \>2x upper limit of normal (ULN) at screening.
* Bilirubin: \>1.5xULN at screening.
* Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example \[e.g.\] Bosniak Category II F, III or IV) \> 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=4 weeks prior to screening.
* Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or epoetin alfa or darbepoetin alfa.
* Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
* Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1).
* Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \>30 days.
* Females only: Subject is pregnant \[as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effective Methods for Avoiding Pregnancy.
* Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
18 Years
99 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Formosa, , Argentina
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Mendoza, , Argentina
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Morón, , Argentina
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San Miguel de Tucumán, , Argentina
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Huntsville, Alabama, United States
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Pine Bluff, Arkansas, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Cerritos, California, United States
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Chula Vista, California, United States
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El Centro, California, United States
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Escondido, California, United States
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Fairfield, California, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Granada Hills, California, United States
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Hacienda Heights, California, United States
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La Mesa, California, United States
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La Palma, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Lynwood, California, United States
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Montebello, California, United States
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Monterey Park, California, United States
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Moreno Valley, California, United States
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Norco, California, United States
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Northridge, California, United States
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Ontario, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Santa Clarita, California, United States
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Simi Valley, California, United States
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Tarzana, California, United States
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Whittier, California, United States
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Whittier, California, United States
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Yorba Linda, California, United States
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Middlebury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Coral Gables, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Ocala, Florida, United States
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Port Charlotte, Florida, United States
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Spring Hill, Florida, United States
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Winter Park, Florida, United States
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Augusta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Meridian, Idaho, United States
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Crystal Lake, Illinois, United States
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Fort Wayne, Indiana, United States
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Jeffersonville, Indiana, United States
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Merrillville, Indiana, United States
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Michigan City, Indiana, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Greenbelt, Maryland, United States
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Takoma Park, Maryland, United States
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Kalamazoo, Michigan, United States
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Pontiac, Michigan, United States
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Roseville, Michigan, United States
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Gulfport, Mississippi, United States
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Tupelo, Mississippi, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Portsmouth, New Hampshire, United States
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Gallup, New Mexico, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Flushing, New York, United States
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New York, New York, United States
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Ridgewood, New York, United States
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The Bronx, New York, United States
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Yonkers, New York, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Sumter, South Carolina, United States
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Cordova, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Beaumont, Texas, United States
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Salem, Virginia, United States
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Bluefield, West Virginia, United States
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Shorewood, Wisconsin, United States
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Burzaco, Buenos Aires, Argentina
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Ciudad Evita, Buenos Aires, Argentina
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Pergamino, Buenos Aires, Argentina
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Pilar, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Concord, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Birtinya, Queensland, Australia
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Herston, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Melbourne, Victoria, Australia
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St Albans, Victoria, Australia
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Nedlands, Western Australia, Australia
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Murdoch, , Australia
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Graz, , Austria
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Sankt Pölten, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Baudour, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Hasselt, , Belgium
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Ieper, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Salvador, Estado de Bahia, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Joinville, Santa Catarina, Brazil
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São José do Rio Preto, São Paulo, Brazil
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Belo Horizonte, Minas Gerais, , Brazil
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Feira de Santana, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Blagoevgrad, , Bulgaria
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Dobrich, , Bulgaria
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Gabrovo, , Bulgaria
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Lom, , Bulgaria
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Lovech, , Bulgaria
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Montana, , Bulgaria
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Pazardzhik, , Bulgaria
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Beroun, , Czechia
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Frýdek-mistek, , Czechia
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Ivančice, , Czechia
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Jilemnice, , Czechia
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Mariánské Lázně, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Sokolov, , Czechia
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Aalborg, , Denmark
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Holstebro, , Denmark
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Kolding, , Denmark
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Odense C, , Denmark
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Svendborg, , Denmark
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Annonay, , France
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Bois-Guillaume, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Caen, , France
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Mulhouse, , France
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Poitiers, , France
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Reims, , France
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Tours, , France
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Mannheim, Baden-Wurttemberg, Germany
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Bad König, Hesse, Germany
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Wiesbaden, Hesse, Germany
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Cloppenburg, Lower Saxony, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Kaiserslautern, Rhineland-Palatinate, Germany
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Kiel, Schleswig-Holstein, Germany
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Dieburg, , Germany
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Freiburg im Breisgau, , Germany
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Minden, , Germany
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Alexandroupoli, , Greece
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Arta, , Greece
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Athens, , Greece
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Heraklion-Crete, , Greece
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Ioannina, , Greece
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Ioannina, , Greece
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Komotini, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Eger, , Hungary
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Esztergom, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Szigetvár, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Bangalore, , India
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Calicut, , India
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Chennai, , India
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Chennai, Tamil Nadu, , India
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Delhi, , India
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Gurgaon, , India
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Hyderabad, , India
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Jaipur, , India
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Mumbai, , India
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Nadiād, , India
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Nagpur, , India
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New Delhi, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Pune, , India
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Secunderabad, , India
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Trivandrum, , India
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Foggia, Apulia, Italy
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Catanzaro, Calabria, Italy
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Reggio Calabria, Calabria, Italy
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Napoli, Campania, Italy
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Piacenza, Emilia-Romagna, Italy
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Genoa, Liguria, Italy
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Bergamo, Lombardy, Italy
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Lecco, Lombardy, Italy
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Milan, Lombardy, Italy
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Monza, Lombardy, Italy
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Pavia, Lombardy, Italy
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Seriate, Lombardy, Italy
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Turin, Piedmont, Italy
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Cagliari, Sardinia, Italy
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Imola, , Italy
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Mestre, , Italy
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Batu Caves, , Malaysia
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George Town, , Malaysia
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Ipoh, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Pahang, , Malaysia
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Saltillo, Coahuila, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Querétaro City, Querétaro, Mexico
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Ciudad de México, State of Mexico, Mexico
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Cuautitlán Izcalli, State of Mexico, Mexico
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Mérida, Yucatán, Mexico
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Chihuahua City, , Mexico
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México, D.F., , Mexico
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Zapopan, Jalisco, , Mexico
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Amsterdam, , Netherlands
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Deventer, , Netherlands
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Rotterdam, , Netherlands
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Hamilton, , New Zealand
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Hastings, , New Zealand
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Otahuhu, , New Zealand
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Oslo, , Norway
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Stavanger, , Norway
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Biała Podlaska, , Poland
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Gdansk, , Poland
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Grójec, , Poland
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Kielce, , Poland
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Koło, , Poland
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Kołobrzeg, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Olkusz, , Poland
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Pruszków, , Poland
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Tomaszów Mazowiecki, , Poland
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Warsaw, , Poland
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Żary, , Poland
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Amadora, , Portugal
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Corroios, , Portugal
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Covilha, , Portugal
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Forte Da Casa, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Mirandela, , Portugal
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Portimão, , Portugal
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Vila Franca de Xira, , Portugal
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Vila Real (Lordelo), , Portugal
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Arad, , Romania
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Bucharest, , Romania
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Reşiţa, , Romania
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Târgu Jiu, , Romania
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Irkutsk, , Russia
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Krasnodar, , Russia
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Mytischi, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Orenburg, , Russia
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Penza, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Volzhsky, , Russia
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Yaroslavl, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Cape Town, , South Africa
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Cape Town, , South Africa
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Anyang-Si, Gyeonggi-do, , South Korea
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Bucheon-si, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Goyang-si, , South Korea
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Goyang-si, , South Korea
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Goyang-si, Gyeonggi-do, , South Korea
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Uijeongbu-si, , South Korea
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Wŏnju, , South Korea
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Majadahonda, Madrid, Spain
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Alcalá de Henares, , Spain
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Aranda de Duero, , Spain
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Badalona, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Ciudad Real, , Spain
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Girona, , Spain
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Guadalajara, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Manises (Valencia), , Spain
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Málaga, , Spain
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Mollet del Vallès, , Spain
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Palma de Mallorca, , Spain
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Sabadell, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Valladolid, , Spain
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Örebro, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
GSK Investigational Site
New Taipei City, , Taiwan
GSK Investigational Site
New Taipei City, , Taiwan
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New Taipei City, , Taiwan
GSK Investigational Site
Tainan City, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
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Taoyuan Hsien, , Taiwan
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Zhongzheng Dist., Taipei, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
GSK Investigational Site
Antalya, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Chernihiv, , Ukraine
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Chernivtsi, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kherson, , Ukraine
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Kiev, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
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Mykolaiv, , Ukraine
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Ternopil, , Ukraine
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Zaporizhzhia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zhytomyr, , Ukraine
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Stevenage, Hertfordshire, United Kingdom
GSK Investigational Site
Preston, Lancashire, United Kingdom
GSK Investigational Site
Wolverhampton, West Midlands, United Kingdom
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Derby, , United Kingdom
GSK Investigational Site
Doncaster, , United Kingdom
GSK Investigational Site
Dundee, , United Kingdom
GSK Investigational Site
Fife, , United Kingdom
GSK Investigational Site
Glasgow, , United Kingdom
GSK Investigational Site
Hull, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Oxford, , United Kingdom
GSK Investigational Site
Salford, , United Kingdom
Countries
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References
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Cunningham JW, Claggett BL, Lopes RD, McMurray JJV, Perkovic V, Carroll K, Hiemstra T, Khavandi K, Lukas MA, Ranganathan P, Shannon J, van Adelsberg J, Singh AK, Solomon SD. Daprodustat and Heart Failure in CKD. J Am Soc Nephrol. 2024 May 1;35(5):607-617. doi: 10.1681/ASN.0000000000000321. Epub 2024 Feb 22.
Macdougall IC, Meadowcroft AM, Blackorby A, Cizman B, Cobitz AR, Godoy S, Jha V, Johansen KL, McMahon G, Obrador GT, Wong MG, Singh AK. Regional Variation of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Global Daprodustat Dialysis Study (ASCEND-D). Am J Nephrol. 2023;54(1-2):1-13. doi: 10.1159/000528696. Epub 2023 Feb 7.
Singh AK, McCausland FR, Claggett BL, Wanner C, Wiecek A, Atkins MB, Carroll K, Perkovic V, McMurray JJV, Wittes J, Snapinn S, Blackorby A, Meadowcroft A, Barker T, DiMino T, Mallett S, Cobitz AR, Solomon SD. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials. Nephrol Dial Transplant. 2023 Jul 31;38(8):1890-1897. doi: 10.1093/ndt/gfac342.
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Singh AK, Carroll K, Perkovic V, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.
Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000541-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
200807
Identifier Type: -
Identifier Source: org_study_id